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Senior Quality Engineer
Cortland, NY
Job Description
Cortland Company Inc. d/b/a Cortland Biomedical seeks a Senior Quality Engineer to establish, implement, and maintain the company's Quality Management System (QMS) in support of ISO 13485:2016 International Standard for Medical Devices and Good Manufacturing Practices. Lead and participate in activities to ensure that the QMS is adequate, suitable, and effective. Duties include:
Minimum Requirements: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 5 years post-baccalaureate, progressive experience as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, and statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets), and ISO 13485 standards.
Alternatively, will accept Master’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 2 years as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets) and ISO 13485 standards.
To apply, send resume to: brandi.ledet@enerpac.com. Reference job title when applying.
- Establish engineering study protocols and final reports (including deviation processing) using statistical methods and analysis in support of NPD/commercial design, manufacturing, and testing. Examples include EIOQ (hardware and software), test method validation (MSA/GR&R), process characterization, OQ, and PQ.
- Participate in and lead product development teams by ensuring design and development planning, input, output, review, verification, validation, and production transfer activities are compliant with established procedures.
- Perform formal problem solving, auditing, risk management (PFMEA), and validation/qualification.
- Use a variety of statistical techniques including normality analysis, GR&R, capability analysis, and hypothesis testing of continuous and attribute data sets.
- Support addition of suppliers to CBM’s ASL including auditing suppliers (finding resolution), implementing SQA’s, managing PPAP deliverables to close, and leading problem-solving to close.
- Complete assigned CAPA’s in a timely manner to prevent occurrence and recurrence of issues using disciplined problem-solving techniques to support investigation, concise problem statement, containment, correction, root cause analysis, corrective and preventive action, and verification of effectiveness.
- Plan, conduct, and report compliant internal audits (including well documented findings) in a timely manner in support of internal audit schedule and QMS requirements.
- Collaborate with others to ensure nonconforming and potentially nonconforming product are accurately documented, identified, segregated, and dispositioned, and associated corrections are implemented.
- Support safety policies and procedures in accordance with site requirements and at the direction of corporate health and safety officials.
- Ensure quality records are established in support of Good Documentation Practices and records are controlled within QCBD for easy identification and retrieval.
- Manage the timely calibration of monitoring and measuring equipment, ensuring out of calibration records are documented to close, all records are reviewed and approved, and records are maintained within QCBD.
- Establish item-specific, statistically based quality plans to ensure receiving, in-process, and final inspection requirements are documented, communicated, and maintained within DHR and QCBD.
- Analyze data to proactively identify trends/opportunities for KPI improvement, risk reduction, and customer satisfaction.
- Provide reports to management and act independently to initiate/lead continuous improvement.
- Assist in training company employees in Quality System related procedures and processes.
- Supervise Quality Technicians in support of QMS roles, responsibility, and goals.
- Work with engineering and operations to ensure that Quality Technician work is prioritized, scheduled, and completed.
- Use a variety of other methods, tools, and technologies to perform job duties including Quality Control Statistical Techniques; problem solving tools including Cause and Effect Diagrams and Five-Why methodology; and Good Documentation Practices.
Minimum Requirements: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 5 years post-baccalaureate, progressive experience as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, and statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets), and ISO 13485 standards.
Alternatively, will accept Master’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 2 years as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets) and ISO 13485 standards.
To apply, send resume to: brandi.ledet@enerpac.com. Reference job title when applying.
Job Summary
Company
Cortland Company Inc.
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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